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The INRatio 2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio 2 PT Monitoring system is intended for use outside the body (in vitro diagnostic use) by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The INRatio 2 PT Monitoring System is not intended to be used for screening purposes.

Like the predicate device, the INRatio 2 PT Monitoring System performs a modified version of the one-stage Prothrombin Time test, using a recombinant human thromboplastin reagent. The clot formed in the Prothrombin Time reaction is detected by a change in the electrical impedance of the sample during the coagulation process. The system consists of a monitor. disposable test strips, instruction manual, quick reference guide, training video/DVD, and testing supplies. The monitor measures impedance, heats the test strip to the proper reaction temperature, and provides a user interface. The Test Strips have not been modified from the design described in K020679.

Here's an analysis of the provided text to extract information about the acceptance criteria and the study proving device performance:

Unfortunately, the provided text does not contain the acceptance criteria or a detailed study description with performance metrics. The document is a 510(k) summary for the INRatio® 2 PT Monitoring System, primarily focusing on its substantial equivalence to a predicate device. It defines the device, its intended use, and presents the FDA's clearance letter.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or other detailed study information. The document explicitly states that the INRatio 2 PT Monitoring System is a "hardware and software modification of the INRatio System" and that "The INRatio 2 and the INRatio have the same intended use and use the same operating principle." This suggests that the substantial equivalence claim relies heavily on the prior clearance of the original INRatio System (K020679) and that extensive new clinical studies to establish new performance criteria were likely not performed as part of this 510(k) submission.

To illustrate what a full answer would look like if the information were present, I'll provide a template with placeholders and explanations for each requested section.

Acceptance Criteria and Device Performance Study Analysis (Based on Hypothetical Data)

As the provided 510(k) summary for the INRatio® 2 PT Monitoring System (K072727) does not explicitly detail acceptance criteria or a specific study proving it meets them beyond a claim of substantial equivalence to its predicate, the following information is presented as a template for what would be expected in such a description. If a detailed study was included, it was not part of the publicly available summary provided.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: (Hypothetical) 500 patient samples
• Data Provenance: (Hypothetical) Prospective study conducted at 3 clinical sites in the United States and Canada.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: (Hypothetical) 2 board-certified clinical pathologists
• Qualifications: Each pathologist had at least 15 years of experience in coagulation testing interpretation and laboratory oversight, specifically with PT/INR assays.

4. Adjudication Method for the Test Set

• Adjudication Method: (Hypothetical) For any discrepancies in ground truth determination between the two primary pathologists (e.g., if a reference result was borderline or technically challenging), a third, equally qualified pathologist would independently review the data, and their decision would serve as the tie-breaker (2+1 method).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• Was it done? No.
• Effect Size: N/A (The INRatio 2 PT Monitoring System is an in-vitro diagnostic device for quantitative measurement rather than an interpretive AI tool. MRMC studies are typically for AI-assisted image interpretation or similar diagnostic tasks where human readers' performance is directly enhanced by AI.)

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Was it done? Yes.
• Details: (Hypothetical) The core analytical algorithm for Prothrombin Time calculation was evaluated in a standalone manner by comparing its output on blood samples with known PT values against a gold-standard laboratory reference method, without human intervention in the calculation process.

7. Type of Ground Truth Used

• Type of Ground Truth: (Hypothetical) Central laboratory reference method (e.g., automated coagulometer using a World Health Organization (WHO) traceable thromboplastin reagent) performed by qualified laboratory personnel, with results cross-verified by expert consensus for ambiguous cases.

8. Sample Size for the Training Set

• Sample Size: (Hypothetical) The device's underlying algorithm (which is a modification of a previously cleared device) did not utilize a "training set" in the machine learning sense. Its calibration and parameter optimization might have been based on historical data or engineering studies (e.g., 1,000 samples for initial parameter tuning).

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth Established: (Hypothetical, assuming no machine learning training set) For any historical data or engineering studies used for parameter optimization, ground truth would have been established through a similar process as the test set: comparison to a validated central laboratory reference method.

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